Health monitoring system

ABSTRACT

A health monitoring system includes a plurality of remote user sites, each remote user site comprising at least one health monitoring device for collection of user health monitoring data, an interactive video device, and a user interface apparatus; at least one remote computing facility configured for signal communication with, and to receive health monitoring data-related signals from, the plurality of remote user sites; and at least one computer, configured for signal communication with the remote computing facility, wherein the interactive video device is interactively coupled with the remote computing facility. Associated methods are also described.

RELATED APPLICATIONS

This application is a Continuation of U.S. patent application Ser. No.09/237,194 filed Jan. 26, 1999, which is a Continuation of U.S. patentapplication Ser. No. 08/481,925 filed Jun. 7, 1995, now U.S. Pat. No.5,899,855, which is a Continuation of U.S. patent application Ser. No.08/233,397 filed Apr. 26, 1994, now abandoned. The contents of theabove-listed applications are incorporated herein by reference in theirentirety.

FIELD OF THE INVENTION

This invention relates to self-care health monitoring arrangements thatenable a patient or other user to gather data important to a healthmanagement program and, if appropriate, provide that data to ahealthcare professional.

BACKGROUND OF THE INVENTION

In the following discussion certain articles and methods will bedescribed for background and introductory purposes. Nothing containedherein is to be construed as an “admission” of prior art. Applicantexpressly reserves the right to demonstrate, where appropriate, that thearticles and methods referenced herein do not constitute prior art underthe applicable statutory provisions. Controlling or curing conditions ofill health generally involves both establishing a therapeutic programand monitoring the progress of the afflicted person. Based on thatprogress, decisions can be made as to altering therapy to achieve a cureor maintain the affliction or condition at a controlled level.Successfully treating certain health conditions calls for ratherfrequent monitoring and a relatively high degree of patientparticipation. For example, in order to establish and maintain a regimenfor successful diabetes care, a diabetic should monitor his or her bloodglucose level and record that information along with the date and timeat which the monitoring took place. Since diet, exercise, and medicationall affect blood glucose levels, a diabetic often must record datarelating to those items of information along with blood glucose level sothat the diabetic may more closely monitor his or her condition and, inaddition, can provide information of value to the healthcare provider indetermining both progress of the patient and detecting any need tochange the patient's therapy program.

Advances in the field of electronics over the past several years havebrought about significant changes in medical diagnostic and monitoringequipment, including arrangements for self-care monitoring of variouschronic conditions. With respect to the control and monitoring ofdiabetes, relatively inexpensive and relatively easy-to-use bloodglucose monitoring systems have become available that provide reliableinformation that allows a diabetic and his or her healthcareprofessional to establish, monitor and adjust a treatment plan (diet,exercise, and medication). More specifically, microprocessor-based bloodglucose monitoring systems are being marketed which sense the glucoselevel of a blood sample that is applied to a reagent-impregnated regionof a test strip that is inserted in the glucose monitor. When themonitoring sequence is complete, the blood glucose level is displayedby, for example, a liquid crystal display (LCD) unit.

Typically, currently available self-care blood glucose monitoring unitsinclude a calendar/clock circuit and a memory circuit that allows anumber of blood glucose test results to be stored along with the dateand time at which the monitoring occurred. The stored test results(blood glucose level and associated time and date) can be sequentiallyrecalled for review by the blood glucose monitor user or a healthprofessional by sequentially actuating a push button or other controlprovided on the monitor. In some commercially available devices, theaverage of the blood glucose results that are stored in the monitor orthe average of the results for a predetermined period of time, (e.g.,fourteen days) also is displayed during the recall sequence. Further,some self-care blood glucose monitors allow the user to tag the testresult with an “event code” that can be used to organize the testresults into categories. For example, a user might use a specific eventcode to identify test results obtained at particular times of the day, adifferent event code to identify a blood glucose reading obtained aftera period of exercise, two additional event codes to identify bloodglucose readings taken during hypoglycemia symptoms and hyperglycemiasymptoms, etc. When event codes are provided and used, the event codetypically is displayed with each recalled blood glucose test result.

Microprocessor-based blood glucose monitoring systems have advantagesother than the capability of obtaining reliable blood glucose testresults and storing a number of the results for later recall and review.By using low power microprocessor and memory circuits and powering theunits with small, high capacity batteries (e.g., a single alkalinebattery), extremely compact and light designs have been achieved thatallow taking the blood glucose monitoring system to work, school, oranywhere else the user might go with people encountered by the user notbecoming aware of the monitoring system. In addition, mostmicroprocessor-based self-care blood glucose monitoring systems have amemory capacity that allows the system to be programmed by themanufacturer so that the monitor displays a sequence of instructionsduring any necessary calibration or system tests and during the bloodglucose test sequence itself. In addition, the system monitors varioussystem conditions during a blood glucose test (e.g., whether a teststrip is properly inserted in the monitor and whether a sufficientamount of blood has been applied to the reagent impregnated portion ofthe strip) and if an error is detected generates an appropriate display(e.g., “retest”). A data port may be provided that allows test resultsstored in the memory of the microprocessor-based blood glucosemonitoring system to be transferred to a data port (e.g., RS-232connection) of a personal computer or other such device for subsequentanalysis.

Microprocessor-based blood glucose monitoring systems are a significantadvance over previously available self-care systems such as thoserequiring a diabetic to apply a blood sample to reagent activatedportions of a test strip; wipe the blood sample from the test stripafter a predetermined period of time; and, after a second predeterminedperiod of time, determine blood glucose level by comparing the color ofthe reagent activated regions of the test strip with a color chartsupplied by the test strip manufacturer. Despite what has been achieved,numerous drawbacks and disadvantages still exist. For example,establishing and maintaining diabetic healthcare often requires thediabetic to record additional data pertaining to medication, foodintake, and exercise. However, the event codes of currently availablemicroprocessor blood glucose monitoring systems provide only limitedcapability for tagging and tracking blood glucose test results accordingto food intake and other relevant factors. For example, the event codesof currently available monitoring systems only allow the user toclassify stored blood glucose readings in a manner that indicates bloodglucose tests taken immediately after a heavy, light or normal meal.This method of recording information not only requires subjectivejudgment by the system user, but will not suffice in a situation inwhich successfully controlling the user's diabetes requires therecording and tracking of relatively accurate information relating tofood intake, exercise, or medication (e.g., insulin dosage). Anotherwise significant advantage of currently available blood glucosemonitoring systems is lost when blood glucose test results must berecorded and tracked with quantitative information relating tomedication, food intake, or exercise. Specifically, the system user mustrecord the required information along with a time and date tagged bloodglucose test result by, for example, writing the information in a logbook.

The use of event codes to establish subcategories of blood glucose testresults has an additional disadvantage or drawback. In particular,although alphanumeric display devices are typically used in currentlyavailable microprocessor-based blood glucose monitoring systems, thedisplay units are limited to a single line of information having on theorder of six characters. Moreover, since the systems include noprovision for the user to enter alphanumeric information, any eventcodes that are used must be indicated on the display in a generic manner(e.g., displayed as “EVENT 1”, “EVENT 2”, etc.) This limitation makesthe system more difficult to use because the diabetic must eithermemorize his or her assignment of event codes or maintain a list thatdefines the event codes. The limited amount of data that can bedisplayed at any one time presents additional drawbacks anddisadvantages. First, instructions and diagnostics that are displayed tothe user when calibrating the system and using the system to obtain ablood glucose reading must be displayed a line at a time and in manycases, the information must be displayed in a cryptic manner.

The above-discussed display limitations and other aspects of currentlyavailable blood glucose monitoring systems is disadvantageous in yetanother way. Little statistical information can be made available to theuser. For example, in diabetic healthcare maintenance, changes orfluctuations that occur in blood glucose levels during a day, a week, orlonger period can provide valuable information to a diabetic and/or hisor her healthcare professional. As previously mentioned, currentlyavailable systems do not allow associating blood glucose test resultswith attendant quantitative information relating to medication, foodintake, or other factors such as exercise that affect a person's bloodglucose level at any particular point in time. Thus, currently availableblood glucose monitoring systems have little or no capability for thegenerating and display of trend information that may be of significantvalue to a diabetic or the diabetic's healthcare professional.

Some currently available blood glucose monitoring systems provide a dataport that can be interconnected with and transfer data to a personalcomputer (e.g., via an RS-232 connection). With such a system and asuitable programmed computer, the user can generate and display trendinformation or other data that may be useful in administering his or hertreatment plan. Moreover, in such systems, data also can be transferredfrom the blood glucose monitoring system to a healthcare professional'scomputer either directly or remotely by telephone if both the bloodglucose monitoring system (or computer) to which the data has beendownloaded and the healthcare professional's computer are equipped withmodems. Although such a data transfer provision allows a healthcareprofessional to analyze blood glucose data collected by a diabetic, thisaspect of currently available blood glucose monitoring systems has notfound widespread application. First, the downloading and subsequentanalysis feature can only be used by system users that have ready accessto a computer that is programmed with appropriate software and, inaddition, have both the knowledge required to use the software (and theinclination to do so). This same problem exists with respect to datatransfer to (and subsequent analysis by) a healthcare professional.Moreover, various manufacturers of systems that currently provide a datatransfer feature do not use the same data format. Therefore, if ahealthcare professional wishes to analyze data supplied by a number ofdifferent blood glucose monitoring systems, he or she must possesssoftware for each of the systems and must learn to conduct the desiredanalyses with each software system.

The above-discussed disadvantages and drawbacks of microprocessor-basedself-care health monitoring systems take on even greater significancewith respect to children afflicted with diabetes, asthma and otherchronic illnesses. In particular, a child's need for medication andother therapy changes as the child grows. Current microprocessor-basedself-care health monitoring systems generally do not provide informationthat is timely and complete enough for a healthcare professional torecognize and avert problems before relatively severe symptoms develop.Too often, a need for a change in medication and/or other changes intherapeutic regimen is not detected until the child's condition worsensto the point that emergency room care is required.

Further, currently available microprocessor-based health monitoringsystems have not been designed with children in mind. As previouslymentioned, such devices are not configured for sufficient ease of use insituations in which it is desirable or necessary to record and trackquantitative information that affects the physical condition of thesystem user (e.g., medication dosage administered by a diabetic and foodintake). Children above the age at which they are generally capable ofobtaining blood samples and administering insulin or other medicationgenerally can learn to use at least the basic blood glucose monitoringfeatures of currently available microprocessor-based blood glucosemonitoring systems. However, the currently available monitoring systemsprovide nothing in the way of motivation for a child to use the deviceand, in addition, include little or nothing that educates the childabout his or her condition or treatment progress.

The lack of provision for the entering of alphanumeric data also can bea disadvantage. For example, currently available blood glucosemonitoring systems do not allow the user or the healthcare professionalto enter information into the system such as medication dosage and otherinstructions or data that is relevant to the user's self-care healthprogram.

The above-discussed disadvantages and drawbacks of currently availablemicroprocessor-based blood glucose monitoring systems also have beenimpediments to adopting the basic technology of the system for otherhealthcare situations in which establishing and maintaining an effectiveregimen for cure or control is dependent upon (or at least facilitatedby) periodically monitoring a condition and recording that conditionalong with time and date tags and other information necessary or helpfulin establishing and maintaining a healthcare program.

SUMMARY OF THE INVENTION

Certain aspects of this invention provide a new and useful system forhealthcare maintenance in which the invention either serves as aperipheral device to (or incorporates) a small handheldmicroprocessor-based unit of the type that includes a display screen,buttons or keys that allow a user to control the operation of the deviceand a program cartridge or other arrangement that can be inserted in thedevice to adapt the device to a particular application or function. Theinvention in effect converts the handheld microprocessor device into ahealthcare monitoring system that has significant advantages oversystems such as the currently available blood glucose monitoringsystems. To perform this conversion, the invention includes amicroprocessor-based healthcare data management unit, a programcartridge and a monitoring unit. When inserted in the handheldmicroprocessor unit, the program cartridge provides the softwarenecessary (program instructions) to program the handheld microprocessorunit for operation with the microprocessor-based data management unit.Signal communication between the data management unit and the handheldmicroprocessor unit is established by an interface cable. A secondinterface cable can be used to establish signal communication betweenthe data management unit and the monitoring unit or, alternatively, themonitoring unit can be constructed as a plug-in unit having anelectrical connector that mates with a connector mounted within a regionthat is configured for receiving the monitoring unit.

According to certain embodiments, in operation, the control buttons orkeys of the handheld microprocessor-based unit are used to select theoperating mode for both the data management unit and the handheldmicroprocessor-based unit. In response to signals generated by thecontrol buttons or keys, the data management unit generates signals thatare coupled to the handheld microprocessor unit and, under control ofthe program instructions contained in the program cartridge, establishan appropriate screen display on the handheld microprocessor-based unitdisplay. In selecting system operating mode and other operations, thecontrol buttons are used to position a cursor or other indicator in amanner that allows the system user to easily select a desired operatingmode or function and provide any other required operator input. In thedisclosed detailed embodiment of the invention several modes ofoperation are made available.

In certain embodiments of the invention, the handheld microprocessorunit is a compact video game system such as the system manufactured byNintendo of America Inc. under the trademark “GAME BOY”. Use of acompact video game system has several general advantages, including thewidespread availability and low cost of such systems. Further, suchsystems include switch arrangements that are easily adapted for use inthe invention and the display units of such systems are of a size andresolution that can advantageously be employed in the practice of theinvention. In addition, such systems allow educational or motivationalmaterial to be displayed to the system user, with the material beingincluded in the program cartridge that provides the monitor systemsoftware or, alternatively, in a separate program cartridge.

The use of a compact video game system for the handheldmicroprocessor-based unit of the invention can be advantageous withrespect to children. Specifically, the compact video game systems of thetype that can be employed in the practice of the invention are wellknown and well accepted by children. Such devices are easily operated bya child and most children are well accustomed to using the devices inthe context of playing video games. Motivational and educationalmaterial relating to the use of the invention can be presented ingame-like or animated format to further enhance acceptance and use ofthe invention by children that require self-care health monitoring.

A microprocessor-based health monitoring system that is configured inaccordance with some embodiments of the invention provides additionaladvantages for both the user and a healthcare professional. Inaccordance with one aspect of the invention, standardized reports areprovided to a physician or other healthcare provider by means offacsimile transmission. To accomplish this, the data management unit ofsome embodiments of the invention include a modem which allows testresults and other data stored in system memory to be transmitted to aremote clearinghouse via a telephone connection. Data processingarrangements included in the clearinghouse perform any requiredadditional data processing; format the standardized reports; and,transmit the reports to the facsimile machine of the appropriatehealthcare professional.

The clearinghouse also can fill an additional communication need,allowing information such as changes in medication dosage or otherinformation such as modification in the user's monitoring schedule to beelectronically sent to a system user. In arrangements that incorporatethis particular aspect of the invention, information can be sent to theuser via a telephone connection and the data management unit modem whena specific inquiry is initiated by the user, or when the userestablishes a telephone connection with the clearinghouse for otherpurposes such as providing data for standardized reports.

The clearinghouse-facsimile aspect of the invention allows a healthcareprofessional to receive timely information about patient condition andprogress without requiring a visit by the patient (system user) andwithout requiring analysis or processing of test data by the healthcareprofessional. In this regard, the healthcare professional need notpossess or even know how to use a computer and/or the softwareconventionally employed for analysis of blood glucose and other healthmonitoring data and information.

The invention may also include provision for data analysis and memorystorage of information provided by the user and/or the healthcareprofessional. In particular, the data management units of the currentlypreferred embodiments of the invention include a data port such as anRS-232 connection that allows the system user or healthcare professionalto establish signal communication between the data management unit and apersonal computer or other data processing arrangement. Blood glucosetest data or other information can then be downloaded for analysis andrecord keeping purposes. Alternatively, information such as changes inthe user's treatment and monitoring regimen can be entered into systemmemory. Moreover, if desired, remote communication between the datamanagement unit and the healthcare professional's computer can beestablished using the clearinghouse as an element of the communicationslink. That is, in the currently preferred arrangements of the inventiona healthcare professional has the option of using a personal computerthat communicates with the clearinghouse via a modem and telephone linefor purposes of transmitting instructions and information to a selecteduser of the system and/or obtaining user test data and information forsubsequent analysis.

The invention can be embodied in forms other than those described above.For example, although small handheld microprocessor-based units such asa handheld video game system or handheld microprocessor-based units ofthe type often referred to as “palm-top” computers provide manyadvantages, there are situations in which other compactmicroprocessor-based units can advantageously be used. Among the varioustypes of units that can be employed are using compact video game systemsof the type that employ a program cartridge, but uses a television setor video monitor instead of a display unit that is integrated into thepreviously described handheld microprocessor-based units.

Those skilled in the art also will recognize that the above-describedmicroprocessor-implemented functions and operations can be apportionedbetween one or more microprocessors in a manner that differs from theabove-described arrangement. For example, in some situations, theprogrammable microprocessor-based unit and the program cartridge used inpracticing the invention may provide memory and signal processingcapability that is sufficient for practicing the invention. In suchsituations, the microprocessor of the microprocessor-based datamanagement unit of the above-described embodiments in effect is movedinto the video game system, palm-top, computer or programmablemicroprocessor device. In such an arrangement, the data management unitcan be realized as a relatively simple interface unit that includeslittle or no signal processing capability. Depending upon the situationat hand, the interface unit may or may not include a telephone modemand/or an RS-232 connection (or other data port) for interconnecting thehealthcare system with a computer or other equipment. In othersituations, the functions and operations associated with processing ofthe monitored health care data may be performed by a microprocessor thatis added to or already present in the monitoring device that is used tomonitor blood glucose or other condition.

Because the invention can be embodied to establish systems havingdifferent levels of complexity, the invention satisfies a wide range ofself-care health monitoring applications. The arrangements that includea modem (or other signal transmission facility) and sufficient signalprocessing capability can be employed in situations in which reports areelectronically transmitted to a healthcare professional either in hardcopy (facsimile) form or in a signal format that can be received by andstored in the healthcare professional's computer. On the other hand,less complex (and, hence, less costly) embodiments of the invention areavailable for use in which transfer of system information need not bemade by means of telephonic data transfer or other remote transmissionmethods. In these less complex embodiments, transfer of data to ahealthcare professional can still be accomplished. Specifically, if theprogram cartridge includes a battery and suitable program instructions,monitored healthcare data can be stored in the program cartridge duringuse of the system as a healthcare monitor. The data cartridge can thenbe provided to the healthcare professional and inserted in aprogrammable microprocessor-based unit that is the same as or similar tothat which was used in the healthcare monitoring system. The healthcareprofessional can then review the data, and record it for later use,and/or can use the data in performing various analyses. If desired, themicroprocessor-based unit used by the healthcare professional can beprogrammed and arranged to allow information to be stored in thecartridge for return to and retrieval by the user of the healthcaremonitoring system. The stored information can include messages (e.g.,instructions for changes in medication dosage) and/or programinstructions for reconfiguring the program included in the cartridge soas to effect changes in the treatment regimen, the analyses or reportsto be generated by the healthcare monitoring system, or less importantaspects such as graphical presentation presented during the operation ofthe healthcare system.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing aspects and many of the attendant advantages of thisinvention will become more readily appreciated as the same becomesbetter understood by reference to the following detailed description,when taken in conjunction with the accompanying drawings, wherein:

FIG. 1 is a block diagram that illustrates a healthcare monitoringsystem arranged in accordance with the invention;

FIG. 2 diagrammatically illustrates monitoring systems constructed inaccordance with the invention connected in signal communication with aremotely located computing facility which includes provision for makingthe data supplied by the monitoring system of the invention available toa designated healthcare professional and/or for providing data andinstructions to the system user;

FIG. 3 is a block diagram diagrammatically depicting the structuralarrangement of the system data management unit and its interconnectionwith other components of the system shown in FIG. 1;

FIGS. 4-10 depict typical system screen displays of data and informationthat can be provided by the arrangements shown in FIGS. 1-3; and

FIG. 11 diagrammatically illustrates an alternative healthcaremonitoring system that is arranged in accordance with the invention.

DETAILED DESCRIPTION

FIG. 1 depicts a self-care health monitoring system arranged inaccordance with the invention. In the arrangement shown in FIG. 1, adata management unit 10 is electrically interconnected with a handheldmicroprocessor-based unit 12 via a cable 14. In the depictedarrangement, data management unit 10 also is electrically interconnectedwith a blood glucose monitor 16 of the type capable of sensing bloodglucose level and producing an electrical signal representative thereof.Although FIG. 1 illustrates blood glucose monitor 16 as being connectedto data management unit 10 by a cable 18, it may be preferable toconstruct blood glucose monitor 16 as a plug-in unit that is placed in arecess or other suitable opening or slot in data management unit 10.Regardless of the manner in which blood glucose monitor 16 isinterconnected with data management unit 10, both that interconnectionand cable 14 are configured for serial data communication between theinterconnected devices.

Also shown in FIG. 1 are two additional monitoring devices and 22, whichare electrically connected for serial data communication with datamanagement unit 10 via cables 24 and 26, respectively. Monitoring units20 and 22 of FIG. 1 represent devices other than blood glucose monitor16 that can be used to configure the invention for self-care healthmonitoring applications other than (or in addition to) diabetes care.For example, as is indicated in FIG. 1, the monitoring device 20 can bea peak-flow meter that provides a digital signal representative of theairflow that results when a person suffering from asthma or anotherchronic respiratory affliction expels a breath of air through the meter.As is indicated by monitor 22 of FIG. 1, various other devices can beprovided for monitoring conditions such as blood pressure, pulse, andbody temperature to thereby realize systems for self-care monitoring andcontrol of conditions such as hypertension, certain heart conditions andvarious other afflictions and physical conditions. Upon understandingthe hereinafter discussed aspects and features of the invention it willbe recognized that the invention is easily implemented for these andother types of healthcare monitoring. In particular, monitors used inthe practice of the invention can be arranged in a variety of ways aslong as the data to be recorded or otherwise employed by handheldmicroprocessor unit 12 and/or data management unit 10 is provided inserial format in synchronization with clock signals provided by datamanagement unit 10. As is the case with blood glucose monitor 16, theadditional monitors can be configured as plug-in units that are directlyreceived by data management unit 10, or can be connected to datamanagement unit 10 with cables (as shown in FIG. 1).

As is shown in FIG. 1, handheld microprocessor unit 12 includes adisplay screen 28 and a plurality of switches or keys (30, 32, 34, 36,and 38 in FIG. 1), which are mounted on a housing 40. Located in theinterior of housing 40, but not shown in FIG. 1, are a microprocessor,memory circuits, and circuitry that interfaces switches 30, 32, 34, 36and 38 with the microprocessor. Stored in the memory of program handheldmicroprocessor unit 12 is a set of program instructions that establishesa data protocol that allows handheld microprocessor unit 12 to performdigital data signal processing and generate desired data or graphics fordisplay on display unit 28 when a program cartridge 42 is inserted in aslot or other receptacle in housing 40. That is, program cartridge 42 ofFIG. 1 includes read-only memory units (or other memory means such asbattery-powered random access memory) which store program instructionsand data that adapt handheld microprocessor 12 for operation in a bloodglucose monitoring system. More specifically, when the instructions anddata of program cartridge 42 are combined with program instructions anddata included in the internal memory circuits of handheld microprocessorunit 12, handheld microprocessor unit 12 is programmed for processingand displaying blood glucose information in the manner described belowand additional monitors 22 to provide health monitoring for asthma andvarious other previously mentioned chronic conditions. In each case, theplurality of switches or keys (30, 32, 34, 36, and 38 in FIG. 1) areselectively operated to provide signals that result in pictorial and/oralphanumeric information being displayed by display unit 42.

Various devices are known that meet the above-set forth description ofhandheld microprocessor unit 12. For example, compact devices areavailable in which the plurality of keys allows alphanumeric entry andinternal memory is provided for storing information such as names,addresses, phone numbers, and an appointment calendar. Small programcartridges or cards can be inserted in these devices to program thedevice for various purposes such as the playing of games, spreadsheetapplication, and foreign language translation sufficient for use intravel. More recently, less compact products that have more extensivecomputational capability and are generally called “palm-top” computershave been introduced into the marketplace. These devices also caninclude provision for programming the device by means of an insertableprogram card or cartridge.

The currently preferred embodiments of the invention are configured andarranged to operate in conjunction with yet another type of handheldmicroprocessor unit. Specifically, in the currently preferredembodiments of the invention, program cartridge 42 is electrically andphysically compatible with commercially available compact video gamesystems, such as the system manufactured by Nintendo of America Inc.under the trademark “GAME BOY”. Configuring data management unit 10 andprogram cartridge 42 for operation with a handheld video game system hasseveral advantages. For example, the display unit of such a deviceprovides display resolution that allows the invention to display bothmulti-line alphanumeric information and graphical data. In this regard,the 160×144 pixel dot matrix-type liquid crystal display screencurrently used in the above-referenced compact video game systemsprovides sufficient resolution for at least six lines of alphanumerictext, as well as allowing graphical representation of statistical datasuch as graphical representation of blood glucose test results for aday, a week, or longer.

Another advantage of realizing handheld microprocessor unit 12 in theform of a compact video game system is the relatively simple, yetversatile arrangement of switches that is provided by such a device. Forexample, as is indicated in FIG. 1, a compact video game system includesa control pad 30 that allows an object displayed on display unit 42 tobe moved in a selected direction (i.e., up-down or left-right). As alsois indicated in FIG. 1, compact video game systems typically provide twopair of distinctly-shaped push button switches. In the arrangement shownin FIG. 1, a pair of spaced-apart circular push button switches (36 and38) and a pair of elongate switches (32 and 34) are provided. Thefunctions performed by the two pairs of switches is dependent upon theprogram instructions contained in each program cartridge 42.

Yet another advantage of utilizing a compact video game system forhandheld microprocessor-based unit 12 of FIG. 1 is the widespreadpopularity and low cost of such units. In this regard, manufacture andsale of a data management unit 10, blood glucose monitor 16 and programcartridge 42 that operate in conjunction with a compactmicroprocessor-based video allows the self-care health monitoring systemof FIG. 1 to be manufactured and sold at a lower cost than could berealized in an arrangement in which handheld unit 12 is designed andmanufactured solely for use in the system of FIG. 1.

An even further advantage of using a compact video game system forhandheld microprocessor 12 is that such video game systems include meansfor easily establishing the electrical interconnection provided by cable14 in FIG. 1. In particular, such compact video game systems include aconnector mounted to the game unit housing (40 in FIG. 1) and a cablethat can be connected between the connectors of two video game units toallow interactive operation of the two interconnected units (i.e., toallow contemporaneous game play by two players or competition betweenplayers as they individually play identical but separate games). In thepreferred embodiments of the invention, the “two-player” cable suppliedwith the compact video game unit being used as handheld microprocessorunit 12 is used as cable 14 to establish serial data communicationbetween the handheld microprocessor unit 12 (compact video game system)and data management unit 10. In these preferred embodiments, the programinstructions stored on the memory of data management unit 10 and programcartridge 42 respectively program data management unit 10 and thecompact video game system (i.e., handheld microprocessor unit 12) forinteractive operation in which switches 30, 32, 34, 36 and 38 are usedto control the operation of data management unit 10 (e.g., to select aparticular operational mode such as performance of a blood glucose testor the display of statistical test data and, in addition, to controloperation such as selection of an option during operation of the systemin a particular operational mode). In each operational mode, datamanagement unit 10 processes data in accordance with programinstructions stored in the memory circuits of data management unit 10.Depending upon the operational mode selected by the user, data issupplied to data management unit 10 by blood glucose monitor 16, byadditional monitors (20 and 22 in FIG. 1) or any interconnectedcomputers or data processing facility (such as the hereinafter describeduser's computer 48 and clearinghouse 54 of FIG. 1). During suchoperation, mode switches 30, 32, 34, 36 and 38 are selectively activatedso that signals are selectively coupled to the video game system(handheld microprocessor unit 12) and processed in accordance withprogram instructions stored in program cartridge 42. The signalprocessing performed by handheld microprocessor unit 12 results in thedisplay of alphanumeric, symbolic, or graphic information on the videogame display screen (i.e., display unit 28 in FIG. 1), which allow theuser to control system operation and obtain desired test results andother information.

Although the above-discussed advantages apply to use of the invention byall age groups, employing a compact video game system in the practice ofthe invention is of special significance in monitoring a child's bloodglucose or other health parameters. Children and young adults arefamiliar with compact video game systems. Thus, children will accept ahealth monitoring system incorporating a compact video game system morereadily than a traditional system, even an embodiment of the inventionthat uses a different type of handheld microprocessor unit. Moreover, anembodiment of the invention that functions in conjunction with a compactvideo game system can be arranged to motivate children to monitorthemselves more closely than they might otherwise by incorporatinggame-like features and/or animation in system instruction and testresult displays. Similarly, the program instructions can be included inprogram cartridges 41, 42 and 43 (or additional cartridges) that allowchildren to select game-like displays that help educate the child abouthis or her condition and the need for monitoring.

With continued reference to FIG. 1, data management unit 10 of thecurrently preferred embodiments of the invention includes a data port 44that allows communication between data management unit and a personalcomputer 48 (or other programmable data processor). In the currentlypreferred embodiments of the invention, data port 44 is an RS-232connection that allows serial data communication between data managementunit 10 and personal computer 48. In the practice of the invention,personal computer can be used to supplement data management unit 10 by,for example, performing more complex analyses of blood glucose and otherdata that has been supplied to and stored in the memory circuits of datamanagement unit 10. With respect to embodiments of the inventionconfigured for use by a child, personal computer 48 can be used by aparent or guardian to review and analyze the child's progress and toproduce printed records for subsequent review by a healthcareprofessional. Alternatively, personal computer 48 can be used to supplydata to data management unit 10 that is not conveniently supplied byusing handheld microprocessor switches 30, 32, 34, 36 and 38 as anoperator interface to the system shown in FIG. 1. For example, someembodiments of the invention may employ a substantial amount ofalphanumeric information that must be entered by the system user.Although it is possible to enter such data by using switches 30, 32, 34,36 and 38 in conjunction with menus and selection screens displayed ondisplay screen 28 of FIG. 1, it may be more advantageous to use a devicesuch as personal computer 48 for entry of such data. However, ifpersonal computer 48 is used in this manner, some trade-off of systemfeatures may be required because data management unit 10 must betemporarily interconnected with personal computer 48 during theseoperations. That is, some loss of system mobility might result because asuitably programmed personal computer would be needed at each locationat which data entry or analysis is to occur.

As is indicated in FIG. 1, data management unit 10 of the currentlypreferred embodiments of the invention also includes a modem that allowsdata communication between data management unit and a remote computingfacility identified in FIG. 1 as clearinghouse 54 via a conventionaltelephone line (indicated by reference numeral 50 in FIG. 1) and a modem52 that interconnects clearinghouse 54 and telephone line 50. As shallbe described in more detail, clearinghouse computing facility 54facilitates communication between a user of the system shown in FIG. 1and his or her healthcare professional and can provide additionalservices such as updating system software. As is indicated by facsimilemachine 55 of FIG. 1, a primary function of clearinghouse 54 isproviding the healthcare professional with standardized reports 56,which indicate both the current condition and condition trends of thesystem user. Although a single facsimile machine 55 is shown in FIG. 1,it will be recognized that numerous healthcare professionals (and hencefacsimile machine 55) can be connected in signal communication with aclearinghouse 54.

Regardless of whether a compact video game system, another type ofcommercially available handheld microprocessor-based unit, or aspecially designed unit is used, the preferred embodiments of FIG. 1provide a self-care blood glucose monitoring system in which programcartridge 42: (a) adapts handheld microprocessor unit 12 for displayinginstructions for performing the blood glucose test sequence andassociated calibration and test procedures; (b) adapts handheldmicroprocessor unit 12 for displaying (graphically or alphanumerically)statistical data such as blood glucose test results taken during aspecific period of time (e.g., a day, week, etc.); (c) adapts handheldmicroprocessor unit 12 for supplying control signals and signalsrepresentative of food intake or other useful information to datamanagement unit 10; (d) adapts handheld microprocessor unit 12 forsimultaneous graphical display of blood glucose levels with informationsuch as food intake; and, (e) adapts handheld microprocessor unit 12 fordisplaying information or instructions from a healthcare professionalthat are coupled to data management unit 10 from a clearinghouse 54. Themanner in which the arrangement of FIG. 1 implements the above-mentionedfunctions and others can be better understood with reference to FIGS. 2and 3.

Referring first to FIG. 2, clearinghouse 54 receives data from aplurality of self-care microprocessor-based healthcare systems of thetype shown in FIG. 1, with the individual self-care health monitoringsystems being indicated in FIG. 2 by reference numeral 58. Preferably,the data supplied to clearinghouse 54 by each individual self-carehealth monitoring system 58 consists of “raw data” (i.e., test resultsand related data that was stored in memory circuits of data managementunit 10, without further processing by data management unit 10). Forexample, with respect to the arrangement shown in FIG. 1, blood glucosetest results and associated data such as food intake information,medication dosage and other such conditions are transmitted toclearinghouse 54 and stored with a digitally encoded signal thatidentifies both the source of the information (i.e., the system user orpatient) and those having access to the stored information (i.e., thesystem user's doctor or other healthcare professional).

As shall be recognized upon understanding the manner in which itoperates, clearinghouse 54 can be considered to be a central server forthe various system users (58 in FIG. 2) and each healthcare professional60. In that regard, clearinghouse 54 includes conventionally arrangedand interconnected digital processing equipment (represented in FIG. 2by digital signal processor 57) which receives digitally encodedinformation from a user 58 or healthcare professional 60; processes theinformation as required; stores the information (processed orunprocessed) in memory if necessary; and, transmits the information toan intended recipient (i.e., user 58 or healthcare professional 60).

In FIG. 2, rectangular outline 60 represents one of numerous remotelylocated healthcare professionals who can utilize clearinghouse 54 andthe arrangement described relative to FIG. 1 in monitoring andcontrolling patient healthcare programs. Shown within outline 60 is acomputer 62 (e.g., personal computer), which is coupled to clearinghouse54 by means of a modem (not shown in FIG. 2) and a telephone line 64.Also shown in FIG. 2 is the previously mentioned facsimile machine 55,which is coupled to clearinghouse 54 by means of a second telephone line68. Using the interface unit of computer 62 (e.g., a keyboard orpointing device such as a mouse), the healthcare professional canestablish data communication between computer 62 and clearinghouse 54via telephone line 64. Once data communication is established betweencomputer 62 and clearinghouse 54, patient information can be obtainedfrom clearinghouse 54 in a manner similar to the manner in whichsubscribers to various database services access and obtain information.In particular, the healthcare professional can transmit an authorizationcode to clearinghouse 54 that identifies the healthcare professional asan authorized user of the clearinghouse and, in addition, can transmit asignal representing the patient for which healthcare information isbeing sought. As is the case with conventional database services andother arrangements, the identifying data is keyed into computer 62 bymeans of a conventional keyboard (not shown in FIG. 2) in response toprompts that are generated at clearinghouse 54 for display by thedisplay unit of computer 62 (not shown in FIG. 2).

Depending upon the hardware and software arrangement of clearinghouse 54and selections made by the healthcare professional via computer 62,patient information can be provided to the healthcare professional indifferent ways. For example, computer 62 can be operated to access datain the form that it is stored in the memory circuits of clearinghouse 54(i.e., raw data that has not been processed or altered by thecomputational or data processing arrangements of clearinghouse 54). Suchdata can be processed, analyzed, printed and/or displayed by computer 62using commercially available or custom software. On the other hand,various types of analyses may be performed by clearinghouse 54 with theresults of the analyses being transmitted to the remotely locatedhealthcare professional 60. For example, clearinghouse 54 can processand analyze data in a manner identical to the processing and analysisprovided by the self-care monitoring system of FIG. 1. With respect tosuch processing and any other analysis and processing provided byclearinghouse 54, results expressed in alphanumeric format can be sentto computer 62 via telephone line 64 and the modem associated withcomputer 62, with conventional techniques being used for displayingand/or printing the alphanumeric material for subsequent reference.

The arrangement of FIG. 2 also allows the healthcare professional tosend messages and/or instructions to each patient via computer 62,telephone line 64, and clearinghouse 54. In particular, clearinghouse 54can be programmed to generate a menu that is displayed by computer 62and allows the healthcare professional to select a mode of operation inwhich information is to be sent to clearinghouse 54 for subsequenttransmission to a user of the system described relative to FIG. 1. Thissame menu (or related submenus) can be used by the healthcareprofessional to select one or more modes of operation of theabove-described type in which either unmodified patient data or theresults of data that has been analyzed by clearinghouse 54 is providedto the healthcare provider via computer 62 and/or facsimile machine 55.

In the currently contemplated arrangements, operation of the arrangementof FIG. 2 to provide the user of the invention with messages orinstructions such as changes in medication or other aspects of thehealthcare program is similar to the operation that allows thehealthcare professional to access data sent by a patient (i.e.,transmitted to clearinghouse 54 by a data management unit 10 of FIG. 1).The process differs in that the healthcare professional enters thedesired message or instruction via the keyboard or other interface unitof computer 62. Once the data is entered and transmitted toclearinghouse 54, it is stored for subsequent transmission to the userfor whom the information or instruction is intended.

With respect to transmitting stored messages or instructions to a userof the invention, at least two techniques are available. The firsttechnique is based upon the manner in which operational modes areselected in the practice of the invention. Specifically, in thecurrently preferred embodiments of the invention, program instructionsthat are stored in data management unit 10 and program cartridge 42cause the system of FIG. 1 to generate menu screens which are displayedby display unit 28 of handheld microprocessor unit 12. The menu screensallow the system user to select the basic mode in which the system ofFIG. 1 is to operate and, in addition, allow the user to selectoperational subcategories within the selected mode of operation. Varioustechniques are known to those skilled in the art for displaying andselecting menu items. For example, in the practice of this invention,one or more main menus can be generated and displayed which allow thesystem user to select operational modes that may include: (a) a monitormode (e.g., monitoring of blood glucose level); (b) a display mode(e.g., displaying previously obtained blood glucose test results orother relevant information), (c) an input mode (e.g., a mode forentering data such as providing information that relates to thehealthcare regimen, medication dosage, food intake, etc.); and, (d) acommunications mode (for establishing a communication link between datamanagement unit 10 and personal computer 48 of FIG. 1; or between datamanagement unit 10 and a remote computing facility such as clearinghouse54 of FIG. 2).

In embodiments of the invention that employ a compact video game systemfor handheld microprocessor unit 12, the selection of menu screens andthe selection of menu screen items preferably is accomplished insubstantially the same manner as menu screens and menu items areselected during the playing of a video game. For example, the programinstructions stored in data management unit 10 and program cartridge 42of the arrangement of FIG. 1 can be established so that a predeterminedone of the compact video game switches (e.g., switch 32 in FIG. 1)allows the system user to select a desired main menu in the event thatmultiple main menus are employed. When the desired main menu isdisplayed, operation by the user of control pad 30 allows a cursor orother indicator that is displayed on the menu to be positioned adjacentto or over the menu item to be selected. Activation of a switch (e.g.,switch 36 of the depicted handheld microprocessor unit 12) causes thehandheld microprocessor unit 12 and/or data management unit 10 toinitiate the selected operational mode or, if selection of operationalsubmodes is required, causes handheld microprocessor unit 12 to displaya submenu.

In view of the above-described manner in which menus and submenus areselected and displayed, it can be recognized that the arrangement ofFIG. 1 can be configured and arranged to display a menu or submenu itemthat allows the user to obtain and display messages or instructions thathave been provided by a healthcare professional and stored inclearinghouse 54. For example, a submenu that is generated uponselection of the previously mentioned communications mode can includesubmenu items that allow the user to select various communication modes,including a mode in which serial data communication is establishedbetween data management unit 10 and clearinghouse 54 and data managementunit 10 transmits a message status request to clearinghouse 54. Whenthis technique is used, the data processing system of clearinghouse 54is programmed to search the clearinghouse memory to determine whether amessage exists for the user making the request. Any messages stored inmemory for that user are then transmitted to the user and processed fordisplay on display unit 28 of handheld microprocessor unit 12. If nomessages exist, clearinghouse 54 transmits a signal that causes displayunit 28 to indicate “no messages”. In this arrangement, clearinghouse 54preferably is programmed to store a signal indicating that a storedmessage has been transmitted to the intended recipient (user). Storingsuch a signal allows the healthcare professional to determine thatmessages sent to clearinghouse 54 for forwarding to a patient have beentransmitted to that patient. In addition, the program instructionsstored in data management unit 10 of FIG. 1 preferably allow the systemuser to designate whether received messages and instructions are to bestored in the memory of data management-unit for subsequent retrieval orreview. In addition, in some instances it may be desirable to programclearinghouse 54 and data management unit 10 so that the healthcareprofessional can designate (i.e., flag) information such as changes inmedication that will be prominently displayed to the user (e.g.,accompanied by a blinking indicator) and stored in the memory of datamanagement unit 10 regardless of whether the system user designates theinformation for storage.

A second technique that can be used for forwarding messages orinstructions to a user does not require the system user to select a menuitem requesting transmission by clearinghouse 54 of messages that havebeen stored for forwarding to that user. In particular, clearinghouse 54can be programmed to operate in a manner that either automaticallytransmits stored messages for that user when the user operates thesystem of FIG. 1 to send information to the clearinghouse or programmedto operate in a manner that informs the user that messages are availableand allows the user to access the messages when he or she chooses to doso.

Practicing the invention in an environment in which the healthcareprofessional uses a personal computer in some or all of theabove-discussed ways can be very advantageous. On the other hand, theinvention also provides healthcare professionals timely informationabout system users without the need for a computer (62 in FIG. 2) or anyequipment other than a conventional facsimile machine (55 in FIGS. 1 and2). Specifically, information provided to clearinghouse 54 by a systemuser 58 can be sent to a healthcare professional 60 via telephone line68 and facsimile machine 55, with the information being formatted as astandardized graphic or textual report (56 in FIG. 1). Formatting astandardized report 56 (i.e., analyzing and processing data supplied byblood glucose monitor 16 or other system monitor or sensor) can beeffected either by data management unit 10 or within the clearinghousefacility 54. Moreover, various standardized reports can be provided(e.g., the textual and graphic displays discussed below relating toFIGS. 6-10). Preferably, the signal processing arrangement included inclearinghouse 54 allows each healthcare professional 60 to select whichof several standardized reports will be routinely transmitted to thehealthcare professional's facsimile machine 55, and, to do so on apatient-by-patient (user-by-user) basis.

FIG. 3 illustrates the manner in which data management unit 10 isarranged and interconnected with other system components for effectingthe above-described operational aspects of the invention and additionalaspects that are described relative to FIGS. 4-10. As is symbolicallyindicated in FIG. 3, handheld microprocessor unit 12 and blood glucosemonitor 16 are connected to a dual universal asynchronous receivertransmitter 70 (e.g., by cables 14 and 18 of FIG. 1, respectively). Asalso is indicated in FIG. 3 when a system user connects a personalcomputer 48 (or other programmable digital signal processor) to dataport 44, signal communication is established between personal computer48 and a second dual universal asynchronous receiver transmitter 72 ofdata management unit 10. Additionally, dual universal asynchronousreceiver transmitter 72 is coupled to modem 46 so that datacommunication can be established between data management unit 10 and aremote clearinghouse 54 of FIGS. 1 and 2.

Currently preferred embodiments of data management unit 10 include aplurality of signal sensors 74, with an individual signal sensor beingassociated with each device that is (or may be) interconnected with datamanagement unit 10. As previously discussed and as is indicated in FIG.3, these devices include handheld microprocessor unit 12, blood glucosemonitor 16, personal computer 48, remote computing facility 54 and, inaddition, peak-flow meter 20 or other additional monitoring devices 22.Each signal sensor 74 that is included in data management unit 10 iselectrically connected for receiving a signal that will be present whenthe device with which that particular signal sensor is associated isconnected to data management unit 10 and, in addition, is energized(e.g., turned on). For example, in previously mentioned embodiments ofthe invention in which data port 44 is an RS-232 connection, the signalsensor 74 that is associated with personal computer 48 can be connectedto an RS-232 terminal that is supplied power when a personal computer isconnected to data port 44 and the personal computer is turned on. In asimilar manner, the signal sensor 74 that is associated withclearinghouse 54 can be connected to modem 46 so that the signal sensor74 receives an electrical signal when modem 46 is interconnected to aremote computing facility (e.g., clearinghouse 54 of FIG. 2) via atelephone line 50.

In the arrangement of FIG. 3, each signal sensor 74 is a low powerswitch circuit (e.g., a metal-oxide semiconductor field-effecttransistor circuit), which automatically energizes data management unit10 whenever any one (or more) of the devices associated with signalsensors 74 is connected to data management unit 10 and is energized.Thus, as is indicated in FIG. 3 by signal path 76, each signal sensor 74is interconnected with power supply 78, which supplies operating currentto the circuitry of data management unit 10 and typically consists ofone or more small batteries (e.g., three AAA alkaline cells).

The microprocessor and other conventional circuitry that enables datamanagement unit 10 to process system signals in accordance with storedprogram instructions is indicated in FIG. 3 by central processing unit(CPU) 80. As is indicated in FIG. 3 by interconnection 82 between CPU 80and battery 78, CPU 80 receives operating current from power supply 78,with power being provided only when one or more of the signal sensors 74are activated in the previously described manner. A clock/calendarcircuit 84 is connected to CPU 80 (via signal path 86 in FIG. 3) toallow time and date tagging of blood glucose tests and otherinformation. Although not specifically shown in FIG. 3, operating poweris supplied to clock/calendar 84 at all times.

In operation, CPU 80 receives and sends signals via a data bus(indicated by signal path 88 in FIG. 3) which interconnects CPU 80 withdual universal asynchronous receiver transmitters 70 and 72. The databus 88 also interconnects CPU 80 with memory circuits which, in thedepicted embodiment, include a system read-only memory (ROM) 90, aprogram random access memory (RAM) 92, and an electronically erasableread-only memory (EEROM) 94. System ROM 90 stores program instructionsand any data required in order to program data management unit 10 sothat data management unit 10 and a handheld microprocessor unit 12 thatis programmed with a suitable program cartridge 72 provide thepreviously discussed system operation and, in addition, system operationof the type described relative to FIGS. 4-10. During operation of thesystem, program RAM 92 provides memory space that allows CPU 80 to carryout various operations that are required for sequencing and controllingthe operation of the system of FIG. 1. In addition, RAM 92 can providememory space that allows external programs (e.g., programs provided byclearinghouse 54) to be stored and executed. EEROM 94 allows bloodglucose test results and other data information to be stored andpreserved until the information is no longer needed (i.e., untilpurposely erased by operating the system to provide an appropriate erasesignal to EEROM 94).

FIGS. 4-10 illustrate typical screen displays that are generated by thearrangement of the invention described relative to FIGS. 1-3. Referencewill first be made to FIGS. 4 and 5, which exemplify screen displaysthat are associated with operation of the invention in the blood glucosemonitoring mode. Specifically, in the currently preferred embodiments ofthe invention, blood glucose monitor 16 operates in conjunction withdata management unit 10 and handheld microprocessor unit 12 to: (a)perform a test or calibration sequence in which tests are performed toconfirm that the system is operating properly; and, (b) perform theblood glucose test sequence in which blood glucose meter 16 senses theuser's blood glucose level. Suitable calibration procedures for bloodglucose monitors are known in the art. For example, blood glucosemonitors often are supplied with a “code strip” that is inserted in themonitor and results in a predetermined value being displayed and storedin memory at the conclusion of the code strip calibration procedure.When such a code strip calibration procedure is used in the practice ofthe invention, the procedure is selected from one of the system menus.For example, if the system main menu includes a “monitor” menu item, asubmenu displaying system calibration options and an option forinitiating the blood glucose test may be displayed when the monitor menuitem is selected. When a code strip option is available and selected, asequence of instructions is generated and displayed by display screen 28of handheld microprocessor unit 12 to prompt the user to insert the codestrip and perform all other required operations. At the conclusion ofthe code strip calibration sequence, display unit 28 of handheldmicroprocessor unit 12 displays a message indicating whether or not thecalibration procedure has been successfully completed. For example, FIG.4 illustrates a screen display that informs the system user that thecalibration procedure was not successful and that the code strip shouldbe inserted again (i.e., the calibration procedure is to be repeated).As is indicated in FIG. 4, display screens that indicate a potentialmalfunction of the system include a prominent message such as the“Attention” notation included in the screen display of FIG. 4.

As previously indicated, the blood glucose test sequence that isemployed in the currently preferred embodiment of the invention is ofthe type in which a test strip is inserted in a receptacle that isformed in the blood glucose monitor. A drop of the user's blood is thenapplied to the test strip and a blood glucose sensing sequence isinitiated. When the blood glucose sensing sequence is complete, theuser's blood glucose level is displayed.

In the practice of the invention, program instructions stored in datamanagement unit 10 (e.g., system ROM 90 of FIG. 3) and programinstructions stored in program cartridge 42 of handheld microprocessorunit 12 cause the system to display step-by-step monitoring instructionsto the system user and, in addition, preferably result in display ofdiagnostic messages if the test sequence does not proceed in a normalfashion. Although currently available self-containedmicroprocessor-based blood glucose monitors also display testinstruction and diagnostic messages, the invention provides greatermessage capacity and allows multi-line instructions and diagnosticmessages that are displayed in easily understood language rather thancryptic error codes and abbreviated phraseology that is displayed oneline or less at a time. For example, as is shown in FIG. 5, the completeresults of a blood glucose test (date, time of day, and blood glucoselevel in milligrams per deciliter) can be concurrently displayed bydisplay screen 28 of handheld microprocessor unit 12 along with aninstruction to remove the test strip from blood glucose monitor 16.

As previously mentioned, when the blood glucose test is complete, thetime and date tagged blood glucose test result is stored in the memorycircuits of data management unit 10 (e.g., stored in EEPROM 94 of FIG.3).

The arrangement shown and described relative to FIGS. 1-3 also isadvantageous in that data relating to food intake, concurrent medicationdosage and other conditions easily can be entered into the system andstored with the time and date tagged blood glucose test result for laterreview and analysis by the user and/or his or her healthcareprofessional. Specifically, a menu generated by the system at thebeginning or end of the blood glucose monitoring sequence can includeitems such as “hypoglycemic” and “hyperglycemic”, which can be selectedusing the switches of handheld microprocessor unit 12 (e.g., operationof control pad 30 and switch 36 in FIG. 1) to indicate the user wasexperiencing hypoglycemic or hyperglycemic symptoms at the time ofmonitoring blood glucose level. Food intake can be quantitativelyentered in terms of “Bread Exchange” units or other suitable terms by,for example, selecting a food intake menu item and using a submenudisplay and the switches of handheld microprocessor 12 to select andenter the appropriate information. A similar menu item—submenu selectionprocess also can be used to enter medication data such as the type ofinsulin used at the time of the glucose monitoring sequence and thedosage.

As was previously mentioned, program instructions stored in datamanagement unit 10 and program instructions stored in program cartridge42 of handheld microprocessor unit 12 enable the system to displaystatistical and trend information either in a graphic or alphanumericformat. As is the case relative to controlling other operational aspectsof the system, menu screens are provided that allow the system user toselect the information that is to be displayed. For example, in thepreviously discussed embodiments in which a system menu includes a“display” menu item, selection of the menu item results in the displayof one or more submenus that list available display options. Forexample, in the currently preferred embodiments, the user can selectgraphic display of blood glucose test results over a specific period oftime, such as one day, or a particular week. Such selection results indisplays of the type shown in FIGS. 6 and 7, respectively. When bloodglucose test results for a single day are displayed (FIG. 6), the day ofthe week and date can be displayed along with a graphic representationof changes in blood glucose level between the times at which testresults were obtained. In the display of FIG. 6, small icons identifypoints on the graphic representation that correspond to the bloodglucose test results (actual samples). Although not shown in FIG. 6,coordinate values for blood glucose level and time of day can bedisplayed if desired. When the user chooses to display a weekly trendgraph (FIG. 7), the display generated by the system is similar to thedisplay of a daily graph, having the time period displayed inconjunction with a graph that consists of lines interconnecting pointsthat correspond to the blood glucose test results.

The screen display shown in FIG. 8 is representative of statistical datathat can be determined by the system of FIG. 1 (using conventionalcomputation techniques) and displayed in alphanumeric format. Aspreviously mentioned, such statistical data and information in variousother textual and graphic formats can be provided to a healthcareprofessional (60 in FIG. 2) in the form of a standardized report 56(FIG. 1) that is sent by clearinghouse 54 to facsimile machine 55. Inthe exemplary screen display of FIG. 8, statistical data for bloodglucose levels over a period of time (e.g., one week) or, alternatively,for a specified number of monitoring tests is provided. In the exemplarydisplay of FIG. 8, the system (data management unit 10 or clearinghouse54) also calculates and displays (or prints) the average blood glucoselevel and the standard deviation. Displayed also is the number of bloodglucose test results that were analyzed to obtain the average and thestandard deviation; the number of test results under a predeterminedlevel (50 milligrams per deciliter in FIG. 8); and the number of bloodglucose tests that were conducted while the user was experiencinghypoglycemic symptoms. As previously noted, in the preferred embodimentsof the invention, a screen display that is generated during the bloodglucose monitoring sequence allows the user to identify the blood samplebeing tested as one taken while experiencing hyperglycemic orhypoglycemic symptoms and, in addition, allows the user to specify otherrelevant information such as food intake and medication information.

The currently preferred embodiments of the invention also allow the userto select a display menu item that enables the user to sequentiallyaddress, in chronological order, the record of each blood glucose test.As is indicated in FIG. 9, each record presented to the system userincludes the date and time at which the test was conducted, the bloodglucose level, and any other information that the user provided. Forexample, the screen display of FIG. 9 indicates that the user employedhandheld microprocessor unit 12 as an interface to enter data indicatinguse of 12.5 units of regular insulin; 13.2 units of “NPH” insulin; foodintake of one bread exchange unit; and pre-meal hypoglycemic symptoms.

Use of data management unit 10 in conjunction with handheldmicroprocessor unit 12 also allows display (or subsequent generation ofa standardized report 56) showing blood glucose test results along withfood intake and/or medication information. For example, shown in FIG. 10is a daily graph in which blood glucose level is displayed in the mannerdescribed relative to FIG. 6. Related food intake and medication dosageis indicated directly below contemporaneous blood glucose levels byvertical bar graphs.

It will be recognized by those skilled in the art that theabove-described screen displays and system operation can readily beattained with conventional programming techniques of the type typicallyused in programming microprocessor arrangements. It also will berecognized by those skilled in the art that various other types ofscreen displays can be generated and, in addition, that numerous otherchanges can be made in the embodiments described herein withoutdeparting from the scope and the spirit of the invention.

It will also be recognized by those skilled in the art that theinvention can be embodied in forms other than the embodiments describedrelative to FIGS. 1-10. For example, the invention can employ compactvideo game systems that are configured differently than the previouslydiscussed handheld video game systems and palm-top computers. Morespecifically, as is shown in FIG. 11, a self-care health monitoringsystem arranged in accordance with the invention can employ a compactvideo game system of the type that includes one or more controllers 100that are interconnected to a game console 102 via cable 104. As isindicated in FIG. 11, game console 102 is connected to a video monitoror television 106 by means of a cable 108. Although differing inphysical configuration, controller 100, game console 102 and thetelevision or video monitor 106 collectively function in the same manneras the handheld microprocessor 12 of FIG. 1. In that regard, a programcartridge 42 is inserted into a receptacle contained in game console102, with program cartridge 42 including stored program instructions forcontrolling microprocessor circuitry that is located inside game console102. Controller 100 includes a control pad or other device functionallyequivalent to control pad 30 of FIG. 1 and switches that functionallycorrespond to switches 32-38 of FIG. 1.

Regardless of whether the invention is embodied with a handheldmicroprocessor unit (FIG. 1) or an arrangement such as the compact videogame system (FIG. 11), in some cases it is both possible andadvantageous to apportion the signal processing functions and operationsdifferently than was described relative to FIGS. 1-10. For example, insome situations, the microprocessor-based unit that is programmed by acard or cartridge (e.g., handheld unit 12 of FIG. 1 or compact videogame console 102 of FIG. 11) includes memory and signal processingcapability that allows the microprocessor to perform all or most of thefunctions and operations attributed to data management unit 10 of theembodiments discussed relative to FIGS. 1-10. That is, the digitallyencoded signal supplied by blood glucose monitor 16 (or one of the othermonitors 20 and 22 of FIG. 1) can be directly coupled to themicroprocessor included in game console 102 of FIG. 11 or handheldmicroprocessor 12 of FIG. 1. In such an arrangement, the data managementunit is a relatively simple signal interface (e.g., interface unit 110of FIG. 11), the primary purpose of which is carrying signals betweenthe blood glucose monitor 16 (or other monitor) and the microprocessorof game console 102 (FIG. 11) or handheld unit 12 (FIG. 1). In somesituations, the interface unit may consist primarily or entirely of aconventional cable arrangement such as a cable for interconnectionbetween RS-232 data ports or other conventional connection arrangements.On the other hand, as is shown in FIG. 11, signal interface 110 caneither internally include or be connected to a modem 52, which receivesand transmits signals via a telephone line 50 in the manner describedrelative to FIGS. 1 and 2.

It also should be noted that all or a portion of the functions andoperations attributed to data management unit 10 of FIG. 1 can beperformed by microprocessor circuitry located in blood glucose monitor16 (or other monitor that is used with the system). For example, anumber of commercially available blood glucose monitors include aclock/calendar circuit of the type described relative to FIG. 3 and, inaddition, include microprocessor circuitry for generating visual displaysignals and signals representative of both current and past values ofmonitored blood glucose level. Conventional programming and designtechniques can be employed to adapt such commercially available unitsfor the performance of the various functions and operations attributedin the above discussion of FIGS. 1-11 to data management unit 10 and/orthe microprocessors of handheld unit 12 and compact video console 102.In arrangements in which the blood glucose monitor (or other systemmonitor) includes a microprocessor that is programmed to provide signalprocessing in the above-described manner, the invention can use a signalinterface unit 110 of the above-described type. That is, depending uponthe amount of signal processing effected by the monitoring unit (e.g.,blood glucose monitor 16) and the amount of signal processing performedby the microprocessor of video game console 102 (or handheld unit 12),the signal interface required ranges from a conventional cable (e.g.,interconnection of RS232 ports) to an arrangement in which signalinterface 110 is arranged for signal communication with an internal orexternal modem (e.g., modem 52 of FIG. 11) or an arrangement in whichsignal interface 110 provides only a portion of the signal processingdescribed relative to FIGS. 1-10.

The invention also is capable of transmitting information to a remotelocation (e.g., clearinghouse 54 and/or a remotely located healthcareprofessional) by means other than conventional telephone lines. Forexample, a modem (52 in FIGS. 1 and 11) that is configured for use witha cellular telephone system can be employed to transmit the signalsprovided by the healthcare monitoring system to a remote location viamodulated RF transmission. Moreover, the invention can be employed withvarious digital networks such as recently developed interactive voice,video and data systems such as television systems in which a televisionand user interface apparatus is interactively coupled to a remotelocation via coaxial or fiberoptic cable and other transmission media(indicated in FIG. 11 by cable 112, which is connected to television orvideo monitor 106). In such an arrangement, compact video gamecontroller 100 and the microprocessor of video game console 102 can beprogrammed to provide the user interface functions required fortransmission and reception of signals via the interactive system.Alternatively, the signals provided by video game console 102 (orhandheld unit 12 if FIG. 1) can be supplied to the user interface of theinteractive system (not shown in FIG. 11) in a format that is compatiblewith the interactive system and allows the system user interface to beused to control signal transmission between the healthcare system and aremote facility such as clearinghouse 54, FIGS. 1 and 2.

While this invention is satisfied by embodiments in many differentforms, as described in detail in connection with preferred embodimentsof the invention, it is understood that the present disclosure is to beconsidered as exemplary of the principles of the invention and is notintended to limit the invention to the specific embodiments illustratedand described herein. Numerous variations may be made by persons skilledin the art without departure from the spirit of the invention. Theabstract and the title are not to be construed as limiting the scope ofthe present invention, as their purpose is to enable the appropriateauthorities, as well as the general public, to quickly determine thegeneral nature of the invention. Unless the term “means” is expresslyused, none of the features or elements recited herein should beconstrued as means-plus-function limitations pursuant to 35 U.S.C. §112,paragraph 6.

1. A networked health-monitoring system comprising: (a) a plurality ofremote patient sites, each remote patient site including (i) at leastone display, (ii) a hand held unit configured to facilitate collectionof patient health-related data, (iii) a memory within said hand heldunit, and (iv) a processor within said handheld unit configured toexecute program instructions stored in said memory, said programinstructions, when executed by said processor at each remote patientsite, generate health-monitoring related information on the display andcollect said patient health-related data, wherein said programinstructions are stored after being received by said hand held unit fromat least one central server and allow said hand held unit to update saidhealth-monitoring related information presented on the display; (b) atleast one remotely located computing facility including the at least onecentral server connectable for communication with the hand held units atthe remote patient sites via a first network connection; and (c) atleast one health care professional computer configured for signalcommunication with the central server via a second network connection toreceive information based on the patient health-related data collectedat the remote patient sites, wherein hardware and software of thecentral server (i) transmit the program instructions to the hand heldunit at each of the plurality of remote patient sites and (ii) cancommunicate with the hand held units to reconfigure programs stored ateach remote patient site; and wherein the system is configured totransmit a message for display on at least one remote patient sitedisplay.
 2. The system of claim 1, wherein the program instructions forreconfiguring programs effect changes in a treatment regimen, effectchanges in analyses or reports generated by the by the system, or effectchanges in graphical presentations of the system.
 3. The system of claim1, wherein the message includes step-by-step instructions.
 4. The systemof claim 1, wherein the message includes results of a test.
 5. Thesystem of claim 1, wherein the message includes a diagnostic indicationrelated to whether a test has proceeded in a normal fashion.
 6. Thesystem of claim 1, wherein the message is a multi-line message.
 7. Thesystem of claim 1, wherein the message is educational or motivational.8. The system of claim 1, wherein the message is from the health careprofessional computer.
 9. The system of claim 8, wherein the system isconfigured to cause the message to be transmitted to a specific patientat a specific remote patient site.
 10. The system of claim 9, whereinthe system is configured to cause the message to be transmittedautomatically to the patient.
 11. The system of claim 9, wherein thesystem enables the patient to choose when to receive the message. 12.The system of claim 9, wherein the message is stored before beingtransmitted to the patient.
 13. The system of claim 1, wherein thesystem is configured to allow a patient at a respective one of saidremote patient sites to control the display of health-monitoring relatedinformation on the at least one display at the respective remote patientsite using at least one menu.
 14. The system of claim 13, wherein themenu allows the patient to select any operational mode from the setconsisting of: (a) a display mode for displaying relevant information;(b) an input mode for providing information; and (c) a communicationsmode for establishing a link with the central server.
 15. The system ofclaim 13, wherein the menu allows a patient to select a monitoring modein which at least one of the health-monitoring devices is used.
 16. Thesystem of claim 13, wherein the hand held unit is configured tofacilitate collection of the patient health-related data through apatient at the respective remote patient site using buttons, keys orswitches.
 17. The system of claim 13, wherein the menu allows a patientto display at least one message or instruction from a health careprofessional.
 18. The system of claim 17, wherein the system isconfigured to enable the patient to respond to information on thedisplay by using a cursor or other indicator positioned at a selecteditem.